STADA, Alvotech Launch Adalimumab Biosimilar in First Few European Countries

STADA Arzneimittel and Alvotech announced the launch of their high-concentration, citrate-free adalimumab biosimilar (Hukyndra; AVT02) in France, Germany, Finland, and Sweden, with more European countries to come.

The biosimilar to Humira will be offered to patients with rheumatic conditions in a 100-mg/mL high-formulation administered in a 40-mg/0.4-mL custom-designed prefilled auto-injector pen and as a 40-mg/0.4-mL or 80-mg/0.8-mL prefilled syringe.

Hukyndra represents STADA's fifth EU-approved biosimilar, following its epoetin zeta, pegfilgrastim, teriparatide, and bevacizumab biosimilars. In addition to AVT02, Alvotech is developing an ustekinumab biosimilar representing Stelara, which has shown promise in phase 1 and phase 3 trials, and had partnered with BiosanaPharma for a biosimilar to Xolair (omalizumab).

“Although biosimilar medicines have been marketed in Europe for over 16 years, significant unmet needs exist for patients to access key therapies…. Positively impacting the lives of European patients with inflammatory disorders with our high-concentration, citrate-free alternative to Humira is fully in line with STADA’s purpose of caring for people’s health as a trusted partner,” said Bryan Kim, head of global specialty and executive vice president at STADA, in a statement.

AVT02 was granted marketing authorization in the European Union in December 2021 and has been approved in the United Kingdom, Switzerland, Norway, Iceland, Lichtenstein, and Canada. In Canada, AVT02 is marketed under the name Simlandi. Besides Hukyndra, there are 9 other EU-approved adalimumab biosimilars: Amgevita, Amsparity, Hefiya, Hulio, Hyrimoz, Idacio, Imraldi, Libmyris, and Yuflyma.

Alvotech and its commercialization partner Teva Pharmaceuticals are seeking approval for AVT02 with interchangeability status in the United States, where the biosimilar is under review.

“We are thrilled to take this important step with STADA into multiple European markets. The commercial partnership with STADA allows Alvotech to leverage its strengths as a purpose-built [research and development] and manufacturing platform, singularly focused on biosimilars, which are of vital importance for health care systems globally,” commented Anil Okay, chief commercial officer at Alvotech.